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Excipients(품목신고)

약전 통칙에서는 첨가제를 "제제에 함유된 유효성분 이외의 물질로서 의약품의 유용성을 높이고 제제화를 용이하게 하며 제제의 안정화를 도모하고 외관을 좋게 하는 등의 목적으로 사용하는 것이다. 첨가제로는 필요에 따라 부형제, 안정화제, 보존제, 완충제, 교미제, 현탁화제, 유화제, 방향제, 용해보조제, 착색제, 점증제 등을 쓸 수 있다. 다만, 사용하는 첨가제는 그 제제의 투여량에서 직접적인 약리작용을 나타내지 않고 안전하며, 그 제제의 치료 효과를 변하게 하거나 시험에 지장을 주지 않는다."라고 정의하고 있으며 그 사용 목적은 1)안정성, 생체이용률 등 향상 2)보존 또는 사용 중 제제의 품질 유지 3)의약품의 물리적인 성상을 조절하여 약물경제성 증진을 위함이다. 

  • Carboxymethylcellulose sodium (카르복시메틸셀룰로오스나트륨)

    Manufacturer

    Anhui sunhere pharmaceutical excipients

     

    Specification

    USP

     

    품목 신고번호

    11

     

    IUPAC Name

    N/A

     

    Synonyms

    N/A

     

    Description

    Carboxymethylcellulose is a cellulose derivative that consists of the cellulose backbone made up of glucopyranose monomers and their hydroxyl groups bound to carboxymethyl groups. It is added in food products as a viscosity modifier or thickener and emulsifier. It is also one of the most common viscous polymers used in artificial tears, and has shown to be effective in the treatment of aqueous tear-deficient dry eye symptoms and ocular surface staining. The viscous and mucoadhesive properties as well as its anionic charge allow prolonged retention time in the ocular surface. Sodium carboxymethylcellulose is the most commonly used salt.

     

    CAS No.

    9000-11-7

     

    Certificate of Analysis

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  • Croscarmellose sodium (크로스카멜로오스나트륨)

    Manufacturer

    Anhui sunhere pharmaceutical excipients

     

    Specification

    USP

     

    품목 신고번호

    10

     

    IUPAC Name

    acetic acid;2,3,4,5,6-pentahydroxyhexanal

     

    Synonyms

    N/A

     

    Description

    Sodium croscarmellose is an internally cross-linked sodium carboxymethylcellulose for use as a superdisintegrant in pharmaceutical formulations

     

    CAS No.

    9000-11-7

     

    Certificate of Analysis

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  • Glycerin (글리세린)

    Manufacturer

    FPG Oleochemicals

     

    Specification

    USP

     

    품목 신고번호

    1

     

    IUPAC Name

    propane-1,2,3-triol

     

    Synonyms

    1,2,3-propanetriol

    1,2,3-trihydroxypropane

    Glycerin, anhydrous

    Propanetriol

    Trihydroxypropane

     

    Description

    Glycerol (/ˈɡlɪsərɒl/; also called glycerine or glycerin) is a simple polyol compound. It is a colorless, odorless, viscous liquid that is sweet-tasting and non-toxic. The glycerol backbone is found in those lipids known as glycerides. Due to having antimicrobial and antiviral properties it is widely used in FDA approved wound and burn treatments. It can also be used as an effective marker to measure liver disease. It is also widely used as a sweetener in the food industry and as a humectant in pharmaceutical formulations. Owing to the presence of three hydroxyl groups, glycerol is miscible with water and is hygroscopic in nature.

     

    CAS No.

    56-81-5

     

    Certificate of Analysis

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  • Hypromellose 2208 (히프로멜로오스2208)

    Manufacturer

    Anhui sunhere pharmaceutical excipients

     

    Specification

    USP

     

    품목 신고번호

    3

     

    IUPAC Name

    N/A

     

    Synonyms

    Cellulose hydroxypropyl methyl ether

    Cellulose, 2-hydroxypropyl methyl ether

    Hydroxypropyl methylcellulose 2208

    Hydroxypropyl methylcellulose 2910

    Hydroxypropyl methylcellulose 4000

    Hydroxypropyl methylcelluloses

    Hydroxypropylmethylcellulose

     

    Description

    Hypromellose, or hydroxypropyl methylcellulose (HPMC), is a semisynthetic, inert, and viscoelastic polymer that forms a colloid solution when dissolved in water. It acts as a thickening agent, coating polymer, bioadhesive, solubility enhancer in solid dispersions, and binder in the process of granulation and in modified release formulations. It is a commonly used as a delivery component in oral pharmaceutical products that provides the release of a drug in a controlled fashion, effectively increasing the duration of release of a drug to prolong its therapeutic effects. Hypromellose is also found in eye drops as a lubricant.

     

    CAS No.

    9004-65-3

     

    Certificate of Analysis

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  • Hypromellose 2910 (히프로멜로오스2910)

    Manufacturer

    Anhui sunhere pharmaceutical excipients

     

    Specification

    USP

     

    품목 신고번호

    4

     

    IUPAC Name

    N/A

     

    Synonyms

    Cellulose hydroxypropyl methyl ether

    Cellulose, 2-hydroxypropyl methyl ether

    Hydroxypropyl methylcellulose 2208

    Hydroxypropyl methylcellulose 2910

    Hydroxypropyl methylcellulose 4000

    Hydroxypropyl methylcelluloses

    Hydroxypropylmethylcellulose

     

    Description

    Hypromellose, or hydroxypropyl methylcellulose (HPMC), is a semisynthetic, inert, and viscoelastic polymer that forms a colloid solution when dissolved in water. It acts as a thickening agent, coating polymer, bioadhesive, solubility enhancer in solid dispersions, and binder in the process of granulation and in modified release formulations. It is a commonly used as a delivery component in oral pharmaceutical products that provides the release of a drug in a controlled fashion, effectively increasing the duration of release of a drug to prolong its therapeutic effects. Hypromellose is also found in eye drops as a lubricant.

     

    CAS No.

    9004-65-3

     

    Certificate of Analysis

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  • Hypromellose phthalate (히프로멜로오스프탈레이트)

    Manufacturer

    Anhui sunhere pharmaceutical excipients

     

    Specification

    USP

     

    품목 신고번호

    6

     

    IUPAC Name

    N/A

     

    Synonyms

    HydroxyPropyl MethylCellulose Phthalate

    Cellulose, 2-Hydroxypropyl methylether, phthalic acid ester

    HPMCP

     

    Description

    Hypromellose phthalate (hydroxypropyl methylcellulose phthalate, or HPMCP) is a phthalic acid ester of hydroxypropyl methylcellulose. In the pharmaceutical industry, hypromellose phthalate is used as a coating agent for tablets and granules. It is a colorless, odorless white powder.

     

    Hypromellose phthalate was introduced in 1971 as a cellulose derivative for enteric coating. An enteric coating agent is used to protect drugs from degradation by gastric acid or to present them from causing side effects in the stomach. It is widely used as an enteric coating agent by the pharmaceutical industry. HPMCP has been admitted into the U.S. National Formulary (US/NF). HPMCP is also used in sustained-release preparations, in binders and as microcapsule bases.

     

    CAS No.

    9050-31-1

     

    Certificate of Analysis

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  • Low-Substituted Hydroxypropyl Cellulose (저치환도히드록시프로필셀룰로오스)

    Manufacturer

    Anhui sunhere pharmaceutical excipients

     

    Specification

    USP

     

    품목 신고번호

    9

     

    IUPAC Name

    N/A

     

    Synonyms

    N/A

     

    Description

    Hydroxypropyl cellulose is an ether of cellulose where some of the hydroxyl groups of the cellulose have been hydroxypropylated forming -OCH2CH(OH)CH3 groups. Lacrisertis a formulation of hydroxypropyl cellulose that is used for artificial tears. It is used to treat syndromes characterized by insufficient tear production (keratoconjunctivitis sicca), recurrent corneal erosions, decreased corneal sensitivity, exposure and neuroparalytic keratitis, and as a lubricant for artificial eyes. As a food additive, hydroxypropyl cellulose is used as a thickener and as an emulsion stabilizer.

     

    CAS No.

    9004-64-2

     

    Certificate of Analysis

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  • Propylene Glycol (프로필렌글리콜)

    Manufacturer

    Dow Chemical Thailand Ltd.

     

    Specification

    USP

     

    품목 신고번호

    7

     

    IUPAC Name

    propane-1,2-diol

     

    Synonyms

    N/A

     

    Description

    A clear, colorless, viscous organic solvent and diluent used in pharmaceutical preparations.

     

    CAS No.

    57-55-6

     

    Certificate of Analysis

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  • Sodium stearyl fumarate (스테아릴푸마르산나트륨)

    Manufacturer

    Anhui sunhere pharmaceutical excipients

     

    Specification

    USP

     

    품목 신고번호

    5

     

    IUPAC Name

    sodium;(E)-4-octadecoxy-4-oxobut-2-enoate

     

    Synonyms

    Pruv

    SODIUM OCTADECYL FUMARATE

    UNII-7CV7WJK4UI

     

    Description

    Sodium Stearyl Fumarate (SSF) is used as a lubricant in tableting to reduce the friction between the tablet and the die wall and to prevent adhesion of the material to punches or the die wall in the pharmaceutical industries. It is used also as a lubricant in the manufacturing of capsules and other oral dosage forms. Sodium stearyl fumarate is also used in food production as a dough conditioner, a conditioning agent, and a stabilizing agent.

     

    CAS No.

    4070-80-8

     

    Certificate of Analysis

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  • Sorbitol Sol.70% (Crystalline) (소르비톨액 결정성)

    Manufacturer

    Ksyap Sweetners Limited

     

    Specification

    EP

     

    품목 신고번호

    8

     

    IUPAC Name

    (2R,3R,4R,5S)-hexane-1,2,3,4,5,6-hexol

     

    Synonyms

    N/A

     

    Description

    A polyhydric alcohol with about half the sweetness of sucrose. Sorbitol occurs naturally and is also produced synthetically from glucose. It was formerly used as a diuretic and may still be used as a laxative and in irrigating solutions for some surgical procedures.

     

    CAS No.

    50-70-4

     

    Certificate of Analysis

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  • Sorbitol Sol.70% (Non Crystalline) (소르비톨액70%비결정성)

    Manufacturer

    Ksyap Sweetners Limited

     

    Specification

    EP

     

    품목 신고번호

    2

     

    IUPAC Name

    (2R,3R,4R,5S)-hexane-1,2,3,4,5,6-hexol

     

    Synonyms

    (−)-sorbitol

    D-(−)-sorbitol

    D-glucitol

    D-Sorbitol

    G-ol

    L-Gulitol

     

    Description

    A polyhydric alcohol with about half the sweetness of sucrose. Sorbitol occurs naturally and is also produced synthetically from glucose. It was formerly used as a diuretic and may still be used as a laxative and in irrigating solutions for some surgical procedures.

     

    CAS No.

    50-70-4

     

    Certificate of Analysis

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